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FDA 510(k)

GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RESISTANCE FINGERTIP PROTECTION

K-Number: K003063 · 2000-11-22

ApplicantGimbel Glove Co., LLC
Decision Date2000-11-22
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RESISTANCE FINGERTIP PROTECTION is the device name listed in this FDA 510(k) record. The listed applicant is Gimbel Glove Co., LLC. It received FDA 510(k) clearance on 2000-11-22 under 510(k) number K003063. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RESISTANCE FINGERTIP PROTECTION?

GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RESISTANCE FINGERTIP PROTECTION is a medical device that received FDA 510(k) clearance on 2000-11-22. The listed applicant is Gimbel Glove Co., LLC. The 510(k) number is K003063.

When did GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RESISTANCE FINGERTIP PROTECTION receive FDA 510(k) clearance?

GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RESISTANCE FINGERTIP PROTECTION received FDA 510(k) clearance on 2000-11-22, under 510(k) number K003063.

Who is the listed applicant for GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RESISTANCE FINGERTIP PROTECTION?

The FDA 510(k) record lists Gimbel Glove Co., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RESISTANCE FINGERTIP PROTECTION?

The FDA product code for GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RESISTANCE FINGERTIP PROTECTION is KGO.

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Related Devices (Code: KGO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl CitrateHartalega NGC Sdn. Bhd.K253060Sterile Latex Powder Free Surgical GlovesProtect Gloves Company LimitedK250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbHK240790Polyisoprene Surgical glovesSuzhou Colour-Way New Material Co., Ltd.K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and FentanylWrp Asia Pacific Sdn. Bhd.K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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